Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801211
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-13
First Post:
2023-03-08
Brief Title:
Colonic Resection or Stoma or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer
Sponsor:
Azienda Sanitaria di Firenze
Organization:
Azienda Sanitaria di Firenze
Study Overview
Official Title:
Colonic Resection stOma or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer The CROSCO-1 Multicenter Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CROSCO-1
Brief Summary:
CROSCO-1 study is a national multi-center prospective observational study presenting patients to the emergency departments of the participating centers with obstructive left colon cancer in the absence of metastases and peritoneal carcinomatosis undergoing primary surgical tumor resection with a primary colorectal anastomosis associated or not with a diverting loop ileostomy or without a primary anastomosis Hartmanns procedure or staged resection after endoscopic stenting with Self-expandable Metallic Stent SEMS
The main questions it aims to answer are
the Stoma rate at 1 year after tumor resection
the 30-day and 90-day major morbidity and mortality
1-year quality of life EQ-5D-5L test
Timing of chemotherapy initiation and type of chemotherapy regimen Participants will have an obstructive left colon cancer localized no peritoneal carcinosis or distant metastasis
Researchers will compare primary surgical tumor resection with a primary colorectal anastomosis associated or not with a diverting loop ileostomy or an Hartmanns procedure with a staged resection after endoscopic stenting with SEMS
The main questions it aims to answer are
the Stoma rate at 1 year after tumor resection
the 30-day and 90-day major morbidity and mortality
1-year quality of life EQ-5D-5L test
Timing of chemotherapy initiation and type of chemotherapy regimen Participants will have an obstructive left colon cancer localized no peritoneal carcinosis or distant metastasis
Researchers will compare primary surgical tumor resection with a primary colorectal anastomosis associated or not with a diverting loop ileostomy or an Hartmanns procedure with a staged resection after endoscopic stenting with SEMS
Detailed Description:
Since surgical and oncological outcomes of the different treatment strategies for obstructing left colon cancers have not been studied on a large scale globally we launched the CROSCO-1 study intending to compare the clinical results of all these therapeutic regimens in a cohort of patients treated for obstructive left-sided colorectal cancer CRC
The primary aim of the CROSCO-1 Colonic Resection stOma or self-expanding metal Stents for obstruCtive left cOlon cancer study is to describe the outcomes of the management of emergency presentations of obstructive left CRC with colorectal resection with or without primary anastomosis versus the staged approach with SEMS insertion and subsequent colorectal resection The primary aim of the CROSCO-1 study will be the 1-year stoma rate of patients undergoing primary emergency surgical resection Hartmann procedure or primary resection and anastomosis compared with patients undergoing staged resection emergency endoscopic treatment with SEMS followed by elective resection Other outcomes will be 30-day and 90-day major morbidity and mortality 1-year quality of life and the timing and type of chemotherapy initiation in the two groups
The primary aim of the CROSCO-1 Colonic Resection stOma or self-expanding metal Stents for obstruCtive left cOlon cancer study is to describe the outcomes of the management of emergency presentations of obstructive left CRC with colorectal resection with or without primary anastomosis versus the staged approach with SEMS insertion and subsequent colorectal resection The primary aim of the CROSCO-1 study will be the 1-year stoma rate of patients undergoing primary emergency surgical resection Hartmann procedure or primary resection and anastomosis compared with patients undergoing staged resection emergency endoscopic treatment with SEMS followed by elective resection Other outcomes will be 30-day and 90-day major morbidity and mortality 1-year quality of life and the timing and type of chemotherapy initiation in the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None